The following data is part of a premarket notification filed by N Spine, Inc. with the FDA for Nfix Ii Pedicle Screw System.
| Device ID | K061774 |
| 510k Number | K061774 |
| Device Name: | NFIX II PEDICLE SCREW SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | N SPINE, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Contact | R. Stephen Reitzler |
| Correspondent | R. Stephen Reitzler N SPINE, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-06-23 |
| Decision Date | 2006-12-13 |
| Summary: | summary |